Multiple SclerosisPhase 1/2NCT00248378
Short-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple Sclerosis
A Phase 1/2 study testing Smoked Cannabis in people with Multiple Sclerosis, run by Center for Medicinal Cannabis Research at 1 site in United States.
Trial summary
The purpose of this study is to determine whether or not smoked marijuana improves spasticity in patients with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Smoked Cannabis
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Mar 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically definite or probable, laboratory-supported MS
- Complaints of spasticity and at least moderate increase in tone as evidenced by a score of >= 2 on the Modified Ashworth Scale at either the elbow, hip, or knee
- If on disease-modifying therapy ("ABC"), have been on a stable dose for at least six months
- Fluent in English
- If not cannabis-naive, must refrain from smoking cannabis for two weeks prior to screening (confirmed by urinalysis)
- If on either lioresal (Baclofen) or tizanadine (Zanaflex), have been on a stable dose for at least three months
- >=18 years of age
Who cannot join
- Axis I psychiatric disorder especially depression or significant neurological disease other than MS as determined by the PI
- Recent history of active substance abuse defined as daily use for at least 14 days within the past month
- Drug use restrictions, eg, subjects on probation or parole, employment involving high risk to themselves and/or the public (airline pilot, bus driver, etc.)
- Any unstable medical health problem
- Any known pulmonary disorders, including tuberculosis, asthma, or COPD
- Pregnant or nursing
- Require benzodiazepines to control spasticity
- Require high doses of analgesic medications on a daily basis
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego Medical Center
San Diego, California, 92093
About this study
The purpose of this study is to determine whether or not smoked marijuana improves spasticity in patients with multiple sclerosis.
Read the detailed description
Studies of cannabinoids for spasticity in MS have had mixed results but clinical studies have been small, generally not properly controlled, with results controversial, and difficult to interpret. Recently, investigators in the UK and US tested the ability of cannabinoids to control spasticity and tremor symptoms of the MS-like disease, experimental allergic encephalomyelitis, in mice (Baker et al, 2000). The authors found that four different cannabinoids quantitatively ameliorated both tremor and spasticity in diseased mice; thus providing rationale for patients' reports of the therapeutic effects of cannabis in the control of their MS symptoms.
The present study will be a randomized, placebo-controlled, crossover design of 30 patients who will be assessed before and after treatment for 3 consecutive days (Phase I), undergo washout-out for a total of 11 days, and then cross over to either the placebo or active treatment phase (Phase II), depending on what they received during Phase I. At each study visit, patients will utilize a controlled puff procedure to help ensure stable intake (Levin et al, 1989).
Comparisons: A single dose of 4% THC marijuana cigarette each day for 3 days will be compared to a placebo administered under the same dosing conditions for the relief of spasticity, drug tolerability, and changes in global functioning and quality of life indices.
- Conditions
- Multiple Sclerosis
- Being tested
- Smoked Cannabis
- Keywords
- Multiple Sclerosis, Cannabis, Spasticity, Tolerability
- Medical subject headings
- Multiple Sclerosis, Marijuana Abuse, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoked CannabisDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in spasticity as indicated by the: Ashworth Spasticity Scale, Timed 25-ft Walk, and Grooved Pegboard Test
Secondary outcomes (2)
Tolerability of study drug as determined by the Brief Symptom Inventory, Subjective Ratings of High and Sedation-Revised, and UKU Side Effect Rating Scale
Effect of study drug on global functioning and quality of life as indicated by the Multiple Sclerosis Quality of Life Inventory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study startSep 2001
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Center for Medicinal Cannabis Research
- Sponsor type
- University, hospital or other
- Investigators
- Jody Corey-Bloom, M.D., Ph.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248378
- Sponsor's protocol ID
- C00-SD-103
- Other IDs
- 030002
- Status last verified
- Jun 2006
- First submitted
- 2 Nov 2005
- Last updated
- 23 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00248378
- Acronym / sponsor ID
- C00-SD-103
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Cannabis, Spasticity, Tolerability
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Center for Medicinal Cannabis ResearchUniversity, hospital or other
- Study start
- Sep 2001
- Study completion
- Mar 2005
- First posted
- 4 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether or not smoked marijuana improves spasticity in patients with multiple sclerosis.
Detailed description
Studies of cannabinoids for spasticity in MS have had mixed results but clinical studies have been small, generally not properly controlled, with results controversial, and difficult to interpret. Recently, investigators in the UK and US tested the ability of cannabinoids to control spasticity and tremor symptoms of the MS-like disease, experimental allergic encephalomyelitis, in mice (Baker et al, 2000). The authors found that four different cannabinoids quantitatively ameliorated both tremor and spasticity in diseased mice; thus providing rationale for patients' reports of the therapeutic effects of cannabis in the control of their MS symptoms.
The present study will be a randomized, placebo-controlled, crossover design of 30 patients who will be assessed before and after treatment for 3 consecutive days (Phase I), undergo washout-out for a total of 11 days, and then cross over to either the placebo or active treatment phase (Phase II), depending on what they received during Phase I. At each study visit, patients will utilize a controlled puff procedure to help ensure stable intake (Levin et al, 1989).
Comparisons: A single dose of 4% THC marijuana cigarette each day for 3 days will be compared to a placebo administered under the same dosing conditions for the relief of spasticity, drug tolerability, and changes in global functioning and quality of life indices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinically definite or probable, laboratory-supported MS
- Complaints of spasticity and at least moderate increase in tone as evidenced by a score of >= 2 on the Modified Ashworth Scale at either the elbow, hip, or knee
- If on disease-modifying therapy ("ABC"), have been on a stable dose for at least six months
- Fluent in English
- If not cannabis-naive, must refrain from smoking cannabis for two weeks prior to screening (confirmed by urinalysis)
Key exclusion criteria (8 listed)
- Axis I psychiatric disorder especially depression or significant neurological disease other than MS as determined by the PI
- Recent history of active substance abuse defined as daily use for at least 14 days within the past month
- Drug use restrictions, eg, subjects on probation or parole, employment involving high risk to themselves and/or the public (airline pilot, bus driver, etc.)
- Any unstable medical health problem
- Any known pulmonary disorders, including tuberculosis, asthma, or COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoked Cannabis | Drug | – |
Primary outcome
Reduction in spasticity as indicated by the: Ashworth Spasticity Scale, Timed 25-ft Walk, and Grooved Pegboard Test
2 secondary outcomes
Tolerability of study drug as determined by the Brief Symptom Inventory, Subjective Ratings of High and Sedation-Revised, and UKU Side Effect Rating Scale
Effect of study drug on global functioning and quality of life as indicated by the Multiple Sclerosis Quality of Life Inventory
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2006.
- Center for Medicinal Cannabis ResearchLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jody Corey-Bloom, M.D., Ph.D. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Smoked Cannabis in people with Multiple Sclerosis, run by Center for Medicinal Cannabis Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in spasticity as indicated by the: Ashworth Spasticity Scale, Timed 25-ft Walk, and Grooved Pegboard Test. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2006.